ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Development of an awareness-based intervention to enhance quality of life in severe dementia: a cluster randomised trial across 8 care homes

Acronym

Study hypothesis

Providing care staff with an observational tool that can help to identify evidence of awareness in residents with severe dementia, supported by appropriate training and supervision, will lead to improvements.

Ethics approval

North West Wales Research Ethics Committee approved on the 17th October 2008 (ref: 08/WNo01/60)

Study design

Cluster randomised trial of an observational measure of awareness

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact catherine.quinn@bangor.ac.uk to request a patient information sheet

Condition

Dementia

Intervention

Care staff in homes allocated to the intervention condition will be trained and mentored in using an observational measure of awareness with selected residents over an 8-week period.

The control group will consist of 4 care homes, which will be paired with 4 care homes receiving the intervention. Baseline assessments will be conducted at the control homes after which they will receive no additional input for the 8 week period in which other homes will be receiving the intervention.

Follow-up assessments will be conducted at both homes after the end of the intervention period.

2. Assessment of the person with dementia:2.1. Behaviour: Behavioural Assessment Scale Of Later Life (BASOLL)2.2. Well-being: Positive Response Scale (PRS)2.3. Quality of life: Quality of Life in Late-stage Dementia (QUAL-ID)

All measured at baseline and at the end of the 8 week intervention period.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2010

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Care staff:1.1. Working in the identified homes1.2. All ages, either sex1.3. Permanent employees1.4. Have been in post for at least six months1.5. Work at least 15 hours per week

2. Individuals:2.1. All ages, either sex2.2. Severe dementia2.3. Have no, or only very limited, verbal communication

Participant type

Patient

Age group

Other

Gender

Not Specified

Target number of participants

Up to 80 care staff, observing in total 80 residents with severe dementia

Participant exclusion criteria

1. Agency staff2. Staff who are unable to communicate effectively in English3. Individuals with dementia who are wholly or largely confined to bed

Recruitment start date

01/06/2010

Recruitment end date

28/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Bangor
LL57 2AS
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

School of Psychology Brigantia Building Bangor University Bangor LL57 2AS United Kingdom